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EC number: 947-036-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Rechallenge 2 weeks after primary challenge
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Rechallenge 2 weeks after primary challenge
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test was performed before LLNA became mandatory.
Test material
- Reference substance name:
- Betaines, C12-14 (even numbered)-alkyldimethyl
- EC Number:
- 931-700-2
- Molecular formula:
- C16H33NO2C18H37NO2
- IUPAC Name:
- Betaines, C12-14 (even numbered)-alkyldimethyl
- Test material form:
- other: aqueous formulation
- Details on test material:
- - Name of test material (as cited in study report): Genagen LAB, Hoe S 3838- Substance type: surfactant- Physical state: colourless liquid- Analytical purity: 30% in water- Composition of test material, percentage of components: Free amine: max. 0.5%; sodium chloride 7-8%- Lot/batch No.: DEGE 069380- Expiration date of the lot/batch: January 2005; stable under storage conditions- Stability under test conditions: stable for at least 100 days in water at room temperature- Storage condition of test material: In the original container, at room temperature (range of 20 ± 3 °C), away from direct sunlight- Other: C-chainlengths: ≤ C10: max. 4%; C12: 65-75%; C14: 22-28%; ≥ C16: max. 8%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted (Ibm: GOHI)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: RCC Ltd, Laboratory Animal Services, Fuellinsdorf, Switzerland- Age at study initiation: 5-8 weeks- Weight at study initiation: 346-432 g- Housing: Individually- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418, batch no. 28/03, guinea pig breeding/maintenance diet, containing Vitamin C (Provimi Kliba Ag, Kaiseraugst, Switzerland), ad libitum- Water (e.g. ad libitum): Community tap water from Fuellinsdorf, ad libitum- Acclimation period: 2 weeksENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3- Humidity (%): 30 - 70- Air changes (per hr): 10 - 15 - Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1 %
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1 %
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 20 females, Control group: 10 females
- Details on study design:
- RANGE FINDING TESTS: Two irritation screening tests were performed to determine the appropriate test substance concentrations for induction and challenge. Patching was performed in the same way as in the actual test. The following concentrations were tested: 100, 75, 50, 25 % (Irritations screening I). As the skin of these animals was seriously burnt at all concentrations, and they had to be killed in extremis, a second screening with 5, 3, 1 and 0.3 % (Irritation screen II) was performed. The most representative concentration to stimulate a state of immune hypersensitivity was 5 % used in the induction phase. The highest non-irritating concentration for the challenge was determined as the concentration of 1 % in purified water.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 2 weeks
- Test group: test substance
- Control group: untreated
- Site: left shoulder
- Frequency of applications: once per week (first application on d 0)
- Duration: for 6 hours each
- Concentrations: 5% in purified water
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 29 and 43
- Test group: test substance
- Control group: test substance
- Site: 1st challenge (test and control group): left posterior quadrant of the side and back (2 patches); rechallenge (test group): right flank- Concentrations: 1% in purified water
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches - Challenge controls:
- Actually the control group was a challenge control, as the animals had not been treated in any way during the induction phase.
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Twenty (at the 24-hour reading) and 19 (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent eythema after the challenge treatment with the highest non-irritating concentration of alpha-hexylcinamaldehyde at 5 % in PEG 300. No skin effect was observed in the control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Moderate/confluent erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Moderate/confluent erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Moderate/confluent erythema in one, discrete/patchy erythema in another animal
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Moderate/confluent erythema in one, discrete/patchy erythema in another animal.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy to moderate/confluent erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 5%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/confluent erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Discrete/patchy to moderate/confluent erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5%. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/confluent erythema.
Any other information on results incl. tables
There were no deaths during the course of the study.
No symptoms of systemic toxicity were observed in the animals.
No skin effects were observed in the first and second induction week. In the third week of induction, discrete/patchy to moderate confluent erythema (grade 1 and 2) were observed in 12/20 test animals after treatment with the test item at 5 % in purified water.
Conclusion:
According to the criteria of OECD Guideline 406 Skin Sensitisation the test substance does not have to be considered as sensitising to the skin in a non-adjuvant test system.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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